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Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, When Formulated With Aluminum Hydroxide, AS04, or Without Adjuvant, in Healthy Adult Female Volunteers

Trial Information

Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, When Formulated With Aluminum Hydroxide, AS04, or Without Adjuvant, in Healthy Adult Female Volunteers

This is a Phase II, double-blind, randomized, comparative trial of three formulations of MEDI-517 given at 0, 30, and 180 days by intramuscular injection. The volunteers in this study will be healthy females 18 through 30 years of age. The study collects safety, reactogenicity and immunogenicity data of MEDI-517 with and without adjuvant. Extended follow-up will provide long-term immune response data.

Inclusion Criteria:

- Females 18 through 30 years of age (must not have reached the 31st birthday)

- Written informed consent obtained from the volunteer

- Unless previously surgically sterilized, agrees to use an effective method of birth control beginning 30 days before the first study injection and continuing through 60 days after the final study injection

- Must have a negative serum pregnancy test within 21 days of study entry and must not be breast feeding

- Healthy by medical history and physical examination

- Seronegative for HPV-16 and HPV-18 antibody by ELISA within 21 days of study entry

- History or clinical manifestations of significant medical or psychiatric disorder

- Use of immunosuppressive medication (inhaled and topical corticosteroids are permitted) within the previous 90 days or history of immunodeficiency

- History of cancer

- History of alcohol or drug abuse within the past 2 years

- Abnormal laboratory blood values at screening. Other abnormal laboratory values in the screening panel which in the opinion of the principal investigator are judged to be clinically significant

- Receipt of immunoglobulin or blood products within 90 days prior to study entry

- History of abnormal Pap smear (other than a single prior report of ASCUS or indeterminate Pap smear with a subsequent normal report)

- Genital herpes disease involving the cervix or with disease characterized on examination or by history by extensive external lesions. Volunteers with a history of recurrent genital herpes disease characterized by limited external lesions are eligible to participate in the study.

- Any prior receipt of any vaccine (experimental or otherwise) for treatment or prophylaxis of genital warts or other papillomavirus related condition. Any treatment of genital warts or other papillomavirus related condition within 6 months of randomization (local therapy for common skin and/or plantar warts is allowed)

- Previous administration of any components of the investigational vaccine

- Receipt of any experimental vaccine within 90 days prior to entry into this study

- Receipt of any experimental drug therapy within 30 days or five half-lives of the experimental drug (if the half-life is known), whichever is longer

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